A nobel indictment of gene patenting

Last Updated: Sunday 07 June 2015

You could say that the god has spoken. James D Watson, discoverer of the double helix structure of DNA and winner of the 1962 Nobel Prize for Medicine, says patents on genes are unnecessary. And harmful. And burdens all of society.

In an unexpected amicus curiae brief filed in the US Court of Appeals for the Federal Circuit in the Myriad Genetics case, the celebrated scientist explains how such patents are wrong for scientists, for society and for the human race. Watson, who has been at the forefront of advances in genetic engineering, has written directly to the court “given the significance of the issue at hand”. He believes courts are not able to understand the importance of what is at stake. “What the Court misses, I fear, is the fundamentally unique nature of the human gene. Simply put, no other molecule can store the information necessary to create and propagate life the way DNA does.

It is a chemical entity, but DNA’s importance flows from its ability to encode and transmit the instructions for creating humans. Life’s instructions ought not to be controlled by legal monopolies created at the whim of Congress or the courts,” says the brief filed on June 15. Decades ago he had described as lunacy the patenting of human genes.

But some background on what has stirred this 84-year-old scientist to join issue with this landmark litigation. The brief, interestingly, is “in support of neither party.” The Myriad Genetics case is the most watched patent battle and relates to the right of the Salt Lake-based company to patent two isolated human genes, known as BRCA1 and BRCA2. These account for most inherited forms of breast and ovarian cancers.

Women who test positive using Myriad's gene test, called BRCA Analysis, are said to have a high risk of breast and ovarian cancer.

This column has been following this battle which has divided the scientific community and brought together a large number of organisations from professional pathologists to the American Civil Liberties Union and the Public Patent Foundation to challenge Myriad’s seven patents.

While the majority view appears to be that patenting human DNA is immoral and unethical and impedes genetic research, the biotechnology industry claims that a ruling against gene patenting could have a devastating effect on innovations. While Myriad lost in the lower court, it won on appeal. But in March this year, the Supreme Court sent the case back to the Appeals Court for review.

Hopefully, the Nobel Laureate’s brief in the Myriad case may well change the course of gene patenting in the US—and elsewhere. Here is the nub of his argument and I quote at length: “To this day, we continue to learn how human genes function. We estimate that humans have approximately 22,000 genes.

We have yet to fully understand the functions of all human genes, but this lack of understanding is further reason that scientists should be permitted to experiment on human genes free from any threat of patent infringement. In years to come, with the right advances in genetic engineering, we may well be able to treat or rectify mental disabilities and physical diseases which today are deemed incurable.

Such hope is all the more reason that scientific research on human genes should not be impeded by the existence of unnecessary patents. More importantly, we would not want one individual or company to monopolize the legal right to the beneficial information of a human gene—information that should be used for the betterment of the human race as a whole.”

Why are Watson’s views so important? Recall his role in the Human Genome Project. In 1988, he was appointed associate director for Human Genome Research of the National Institutes of Health (NIH) and, in 1989, Director of the National Center for Human Genome Research at NIH. In these positions, Watson led the public effort to sequence the human genome. “I hope that an awareness of the Human Genome Project’s history will guide the court to the correct decision that human genes, as products of nature, should not be patented.

The Human Genome Project was started not to increase the profits of select companies but to expand our understanding of the human genome and make this information available to all scientists.” Watson also says that if at all gene patents must be given, then compulsory licences should be issued to establish “reasonable access to human genes and genetic information—which is what scientists in general want, had the lawyers and courts not complicated matters”.

One hopes India’s Patent Office will take the trouble of going through this 23-page document which shines a clear light on the muddled thinking on gene patents. It has been quietly awarding such patents.

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